What is Clinical Evaluation?

Clinical evaluation is the proactive, continuous assessment and examination of medical device clinical data using scientific methods to determine their safety and efficacy about their intended purposes and claims made by the manufacturer. The clinical evaluation should begin at the development stage and continue throughout the life cycle of medical devices. As a medical device manufacturer, it is imperative to continually assess the safety and efficacy of your medical device and compile a conclusion report. These reports serve as proof of adherence to regulations.

Clinical evaluation is a key component of the EU MDR 2017/745 technical documentation. There are several reasons why it is required:

• It determines the scientific validity of the device by examining clinical data from multiple sources, such as clinical investigations, published literature, post-market surveillance, and post-market clinical follow-up. This process guarantees that the device’s safety, performance, and clinical benefits claims are substantiated by solid, documented proof.
• Clinical evaluation and risk management processes and interrelated. Risk management helps identify, evaluate, and mitigate potential risks associated with the device. By analyzing clinical data, the risk-benefit profile of the device can be estimated, thereby making decisions on risk management strategies and patient safety.
• Article 61 emphasizes the need for ongoing evaluation, particularly through post-market surveillance (PMS) and Post-Market Clinical Follow-up (PMCF). This continuous monitoring helps identify new risks and ensures that the device remains safe and effective throughout its lifecycle even after being placed on the market.
• The evaluation must demonstrate that the device is safe and effective for the intended user population and clinical indications. This is critical for ensuring that the device performs as expected in real-world settings, reducing the likelihood of adverse events or ineffective treatment
• It must provide a detailed justification of equivalence/similarity, comparing the technical, biological, and clinical characteristics of the devices. This process assures the transferability of clinical data from the equivalent device to the device in the scope.
• The findings from the evaluation lead to decisions on device labelling, instructions for use, contraindications, and precautions. It also helps notified bodies assess whether the device should be approved for market entry or continued use
• The MDR technical documentation with detailed evaluation supports the device’s safety and performance claims. This helps notified bodies review the evaluation methods established as part of the conformity assessment process
• Important for monitoring the safety and performance of a device after it has been approved for use
• A well-conducted evaluation enhances transparency, providing healthcare professionals, patients, and NBs with confidence in the device’s performance and safety.

We are a team of regulatory professionals and CER writers. We solve every obstacle in the path of MDR Article 61 and MEDDEV 2.7/1 Rev. 4 compliance. We provide end-to-end solutions for small, medium, and large-scale medical device manufacturers across the globe.

Our CER writers and experts have a deep understanding of the MDR article 61 requirements, including the specific requirements of different notified bodies. This experience is essential for ensuring that the documentation is accepted by the notified bodies.

The clinical evaluation process is a systematic and ongoing assessment of clinical data to verify the safety and performance of the device throughout its lifecycle. Here’s an overview:

• Through understanding Regulation: EU MDR 2017/745 article 61 section dealing with clinical evaluation and MEDDEV 2.7.1 Rev.4 guidance document
• Clinical Evaluator: Identify a Clinical Evaluator who must have training and experience in the device under evaluation.
• Interpretation of Preclinical Data: The preclinical testing data  to determine the performance and safety based on the benchmark values
• State of the Art: As per 2017/745, the CER must demonstrate the state-of-the-art thorough analysis of various parameters and technologies used for similar devices across the globe.
• Equivalent Device: Devices with the same intended use, same technological characteristics, and biological aspects are considered as equivalent device
• Scientific Literature Search: Scientific literature is a permanent record of collective achievements based on the study, and it is the primary medium for communicating the findings of scientific research.
• Sufficient Clinical Data Collection: Sufficient clinical data are described as data relating to safety, performance, and side effects in medical equipment in the way they are intended to be used from human clinical studies for the topic, basic devices, or equivalent technology.
• Technical Documentation: Technical documentation covers CER in 2017/745 and has been connected through the conformity procedure.
• Post-Market Data: Post-market activities are essential for generating clinical data about medical devices, which can help discover uncommon occurrences and accidents that were previously unknown.

MEDDEV 2.7/1 Rev.4 guides the manufacturers on how to undertake a robust and systematic clinical evaluation and how to demonstrate the scientific validity of the data and conclusions. The important changes and corrections in Rev. 4 are below.

• Frequency of updates of the CERs (clause 6.2.3)
• Qualification of the clinical evaluators or authors (clause 6.4)
• Requirement of specific objective for the CER Consultants which is to be linked to safety performance and risk-benefit endpoints (section 7 and appendix 5)
• Establishing the State of the Art (clause 8.2)
• Requirement of the scientific validity of the different types of dataset (sec 8,9,10 & Appendices: 5,6 & 7)
• Detailed information on the demonstration of equivalence (appendix 1)
• Information on when a clinical investigation is required (Appendix 2)
• Some detailed information on risk-benefit (appendix 7.2)
• Reinforced PMS and PMCF with the clinical evaluation (throughout the guideline)
• Role and actions required by the notified bodies (appendix 12)

We at I3CLOBAL help manufacturers navigate the complex regulatory landscape and ensure the clinical evaluation documentation meets all the requirements. Our medical device consultants have cross-platform expertise and in-depth knowledge of MDR Article 61 and Meddev 2.7/1 Rev.4, so you can start a project right away!

Trying to do it in-house could involve employee hiring, training, and providing the support they need, all of which will cost you time, money, and finally no assurance of success.